Our focus is the creation and submission of real‑world evidence packages that will meet FDA’s stringent requirements.
- DATA
ACCESS - STUDY DESIGN &
PROTOCOL - CDISC
DATA SETS - DATA
ANALYSIS - CLINICAL
STUDY REPORTS - SCIENTIFIC
PUBLICATION - sNDA
SUPPORT - DAC
SUPPORT
As part of any submission process, the data used for regulatory purposes must be submitted to the FDA. You must ensure that patient-level data is allowed to be transferred. Many US commercial claims databases will not allow for data transfer, even to a regulatory agency. This can be an issue for registries as well, if patients did not specifically consent to third-party data sharing. Given GDPR restrictions, most European datasets with patient-level data are prohibited from transfer.
Because of its partnership with Komodo Health, Slipstream IT is able to transfer your data to the FDA, while maintaining the deidentification needed for HIPPA compliance.
- Expert epidemiologists and biostatisticians to design disease-specific external control trials and fully real‑world studies
- Medical writers experienced in traditional RCTs and real-world evidence studies to create efficacy and safety protocols, supplements and statistical analysis plans
We can modify structures as needed to accommodate real‑world data and statistical analysis plans, but always with an eye towards maintaining continuity and consistency.
We work within the Veeva environment to ensure the process of protocol development and submission meets FDA requirements.
Programmers experienced in translating real‑world data into CDISC compliant SDTM and ADaMS datasets.
Our servers are designed to store and process the large data volume required for real‑world datasets.
The ability to validate large data sets using Pinnacle 21, the FDA’s preferred validation software.
Trial master file managed through Veeva Vault with eCTD compliant publishing
When it comes to data submissions, the FDA does not allow for deviations. Experience matters!
- Ability to integrate real‑world data into external control and hybrid controlled trials
- Real‑world data safety event adjudication by experienced physicians
- Experience responding to FDA data requests as well as post hoc data mining
- Clinical trial study reports that integrate real‑world evidence and meet regulatory standards
- Tracking in Veeva Vault and integration into the Trial Master File
- eCTD publishing
- Medical writers experienced in clinical trial publications that integrate real‑world data
- Strong track record of successful manuscript and abstract submission
- Medical writers experienced in regulatory writing
- Ability to create NDA and sNDA sections specific to real‑world data analyses and outcomes
- Ability to submit data through FDA Electronic Submission Gateway
- Experience creating FDA briefing documents specific to real‑world data and analyses
- Ability to quickly respond to FDA data and analytic requests
- Ability to provide real‑time data analyses during Drug Advisory Committee meetings